FDA Inspection 839492 — The American National Red Cross - Southern Region

The American National Red Cross - Southern Region — FEI 1073000

The FDA completed an inspection of The American National Red Cross - Southern Region on Jun 21, 2013 in Douglasville, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jun 21, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Douglasville, GA (United States)

Citations

IDCFRDescription
127021 CFR 211.68(b)input/output verification
139321 CFR 211.103Yield calculations not verified by 2nd person
6721 CFR 606.65(e)Following manufacturer's instructions
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs

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